In an article from Thursday's BBC News, there is now scientific evidence that this is in fact the case. Patients call this syndrome "Chemo Brain." Researchers at the University of Rochester found, in lab tissue samples, that at high chemotherapy treatment doses, not only are cancer cells killed, but also a significant percentage of the normal brain tissue is destroyed.
Lead researcher Dr Mark Noble said: "This is the first study that puts chemo brain on a sound scientific footing, in terms of neurobiology and cellular biology."So, if you're a cancer patient who has received chemotherapy, how do you react to this news? Some may find solace in the fact that for the first time, there is solid scientific data confirming their suspicion of chemotherapy side effects on the brain. Prior to this, cancer patients had to wonder why their doctor did not believe them when they talked about neurological side effects.
The Rochester team carried out tests with three drugs used to treat a wide range of cancers: carmustine, cisplatin and cytosine arabinoside.
All three drugs were toxic to several types of brain cell whose job is to repair other cells in the brain - even at very low concentrations.
For others who have not started chemotherapy, it may make them think twice about receiving treatment. To be honest, I hope that doesn't happen. Being given the diagnosis of cancer is devastating in itself. Treatment options include surgery, chemotherapy, and/or radiation - possibly a combination of these. All carry side effects. But, the alternative of no treatment (depending on the severity of the cancer), has it's own ramifications.
Hopefully, this newly discovered data will assist oncologist researchers to develop neuro-protective properties in chemotherapy agents. Cancer research has always been furious and technology is always changing. I have hope that more treatment options will be available for patients with cancer.
It's creepy that you have picked this topic today. I have just spent the past three hours reading very personal accounts from patients living with (and dying of) cancer.
I needed a break from the sadness and so headed to your blog. *sigh*
How I wish that we could be more on top of this terrible disease.
Hmmm life or damaged brain cells? Personally, I can't see this being the deciding factor about having (or not having) chemo. Maybe I feel a little more strongly (and touchy) about this in lieu of the several times daily updates I receive about our friend who just started radiation yesterday. They wanted to start chemo right around Christmas, so she is going to ask if they can start right after instead of right before.
Have you ever seen a diagram of the human body and that has each body part with a list of the chemo drugs that can really cause some transient to permanent side effects? I mean - I thought I remembered learning about some neurotoxic chemo drugs when I was in nursing school, but perhaps I'm imagining that now and thinking of nephrotoxic, hepatotoxic, ototoxic, etc.
I mean - the deal with cancer...and this is even worse when a child has cancer...is that if a person survives, nobody has really informed them that 5 years down the line, they're going to possibly have a whole host of new medical problems. I "know" this girl who has very bad avascular necrosis from the online AVN support group - they did a joint replacement and she is still in severe pain because the AVN went outside the area of the replacement - and what does that leave? Amputation? Then you just get phantom limb pain....and I can't see any doctor doing this unless the bone literally disintigrates as it rots away (this is how I "see" AVN), and I suppose they could put in a rod or two first? That's not really common. Well any way - this girl, she'd survived bad cancer when she was 17. And now she is in so much pain with the AVN. It sucks....but she has the BEST attitude. She's ALIVE. What's AVN comapared to dying at age 17 from cancer?
It bothered me to read the line that "prior to this, cancer patients had to wonder why their doctor did not believe them when they talked about neurological side effects." Are you serious? If I went through all that chemo and then had memory and other neuro troubles after that, and the doctor didn't believe me, I'd want to dump the chemo back on him to try it out. I would be so pissed. I just feel like that's rather insensitive since we know chemo hurts a lot of the body - who has the right to say that the neuro crap that comes after cancer treatment isn't true...even before this article? Sorry - I don't mean to sound nasty or angry - just a touchy topic for me at the moment!
I would have been mad if my doc hadn't believed the neuro memory and cognitive side effects I got from topamax. And when I started having those side effects, that was listed as an extremely rare complication of topiramate. I believe now the rate of some cognitive impairment related to that drug is 1 in 5. I'm recalling this from what a pharmaceutical rep for the drug told me...stating that with excitement as if to say, "Can you believe it? Only 20% of people experience problems with memory loss and concentration problems!" I just stared at him..."only 20%? Seems like a lot to me..."
I think the best thing about this news (re the chemo) is that it tells patients what to possibly expect. I think when you know of a side effect prior to taking the drug, it's a hell of a lot easier than finding out by getting an unknown side effect afterwards. If you know that memory loss may occur, then it's going to give you time to prepare for that and possibly realize it sooner so as to not get quite so unraveled by it.
Hope I'm not coming across as angry about the topic - I'm not - I think it's an excellent topic to write about. I'm just a bit more touchy than usual about this topic these days. Cancer was always rough after losing Jared but it's currently back in the forefront now that we're dealing with our friend. There's a possibility that it is small cell, but we aren't sure yet. I'm always strong and okay when talking to my mom about it, but then I get into other contexts, and I feel a lot more sensitive. Guess that's normal!
And I will email you back soon - things have just been busy with trying to wrap up my class, being sick, etc. But I appreciate the email.
This reminds me of people wanting to stay of the Statin drugs for fear that it could harm their liver. For a high risk person, the benefit greatly outweighs the risk. I use the analogy that it is like not wanting to jump off of the railroad track with an oncoming train for fear of spraining your ankle.
I know that memory problems and brain loss is a serious thing, but it should shock no one that these poisons we are using to kill cancer cells would cause other problems. While I think this could reassure people who complain of this, I do worry that others will see it as a potential to seek "alternative therapies." People are crazier than you think, neonursechic.
When I was dx'd with cancer almost 12 years ago, the possibility of long-term cognitive dysfunction was not even recognized, let alone discussed.
I'm glad to see that research is finally reinforcing what so many of us have been trying to tell the medical community.
I can't say my cognitive dysfunction is severe or disabling. It's just always there in the background, and it tends to get worse if I'm really tired or stressed out with too much to do. I have a lot of trouble with concentration, multi-tasking and decision-making. If I were in a less cognitive line of work, it might not matter so much, but I really need a brain that functions well. :(
Some of the research has suggested that the cognitive function diminishes or goes away over time. I'm not convinced. Maybe people simply learn how to adapt to it with the passage of time.
I recognize there's a pricetag attached to the privilege of still being alive, but dang... some days the price seems pretty steep and it's not always what I bargained for, you know?
Re the 2nd to last graf in my post above: Make that: "Some research suggests the cognitive DYSfunction diminishes with time."
Duh. I rest my case. ;)
neonursechic, liked your comment.
I can personally attest to the side effects of Topiramate/Topamax and your drug was probably low balling you on that figure. Granted, the problems can improve over time but when you first start the drug you can be dumb as a stump. A lot of anticonvulsants can do that but Topamax hits your temporal lobe (theoretically...) so think about your language centre and where it sits. I believe other AC's aren't as selective with brain regions--they're more global so they tend to just make you clumsy...but also kind of stupid--Topamax just really wins the award for "word finding problems."
But back to the post at hand. Since my knolwedge here is a bit limited, I have a question. Do the chemo drugs cross the blood-brain barrier?
If so it seems like a no brainer. Oops, sorry. I have a bad habit of coming up with unintentional puns. And that one wasn't very funny.
If so, am I *really* oversimplifying things? Cell death is cell death and chemo drugs are there to do a job. Who says that brain cells would necessarily have any special immunity?
If I ever got cancer, regardless of my wacky neuro profile, I'd still go for chemo if it was warranted. I'd fight tooth and nail to stay alive for as long as I could. I haven't fought this hard to stay alive through mental/psych/neuro hell for nothing.
Edited to add: In my second paragraph, I meant to say "...your drug rep.....
Needless to say Topiramate still makes me cognitively impaired as well.
While SOME people may experience neurological side effects I think you have to weigh the pros and cons... may it be as serious as choosing between life and death... I think I would choose the neuro side effects which may diminish over time, rather than death. And with that... I think you have to consider the mental state of your patient when they have to consider their cancer treatments. Their depression they may be experiencing after receiving their diagnosis may have them so down that death may seem the better of the 2 options.
Dr. Rob brings up a good point which I experience every day as well. An argument could be made that cholesterol medicines (statins) are a choice between life and death.
Sure there are people that have the very serious medical side effects (I'm talking rhabdomyolysis), and just cannot take statins.
But, every day in my office, I explain that, bottom line, statins save lives. But, I have many people who refuse to even consider them.
That's how I'm tying in these news reports about chemotherapy. Of course, cancer progression, in general, is more rapid than atherosclerosis progression. But, if I have a patient refuse statins (and is competent to make that decision), then it is their choice - just like the choice to refuse chemotherapy.
Patient autonomy is a 50 page post in itself (don't want to go there now), but I just wanted to highlight "informed refusal" of treatment.
I know of people who have refused chemotherapy because they didn't want to lose their hair. (I hasten to add that for all of them, chemo was adjuvant therapy to surgery and/or radiation. So in sense it wasn't their only option.) But I can appreciate what a double-edged sword this is - acknowledging it on the one hand and scaring patients on the other.
I think what patients most need to hear is, "Yes, this will affect your brain but *we will help you deal with that.*" It's important for us to feel we won't be cast adrift afterwards. This brings up the need for better aftercare and a better transition from active treatment. But that's a whole 'nother topic. :)
Pieces of Mind, I could not agree more with your statement. Great comment!
Well... I have become quite militant on this topic. ;)
Seriously, I appreciate that you posted about it and that there has been some great discussion.
I have heard Topamax called "Dope-a-max." It makes you...uh...forget words.
I have one patient who also skipped chemo - it was adjuvant chemo (to prevent microscopic spread), but he did not want the side effects. He died of his cancer and probably would have been cured.
Patients should be able to make informed choices, but the problem is that they get their information from bad places. They have an uncle who did not do chemo and he did fine. The alternative medicine people convince them of the dangers of chemo (again, duh! Of course it is dangerous) and they go to Mexico for alternative treatments or get Chelation therapy. It does come down to the skill of the doctor in communicating the risk of not doing a treatment and also the patient's pre-conceived ideas.
In the end, however, you cannot force a treatment on someone if they are choosing for themselves. With kids, however, it is a whole different matter!
I've had a total of 28 chemo treatments, 4 different combinations, and I do not think I've suffered "chemo brain". Certainly the anti-emetic drugs have had effects and the anxiety and illness have affected my thinking. However, afterwards, even a couple of weeks later, I've felt normal.
I'm concerned this will become self-fullfilling; people will show effects because they expect them. I do NOT question that many chemo patients do get the brain effects.
Side effects from chemo are not uniformly serious, even for the same protocol.
I'm so with dr.K. I need it too. Wish it was as easy as heading to another blog.
Sure, some people will use this to fuel their alternatives fire, but I still don't believe that the majority of cancer patients think this way. There have been a few high profile cases of this lately that I think we all know of. And most of us who work in the medical field have seen these types. I've seen them in friends and some family. Oddly enough, when I was in nursing school, I can't tell you the amount of nursing students who would say, "Oh no...I don't take medication. I don't put chemicals into my body." Then....why are you becoming a nurse? Isn't that a conflict of interest? And I'm not talking people who don't want to take antidepressants or anticonvulsants, etc - I'm talking about people who don't want to take an advil for pain, etc. They're out there. Lots of them!
Personally, I often get targeted by them. I thought I'd moved past that since a lot of people now know the extent of what I've been through, but the other day, I went to the apartment office, and the apartment manager was asking me about my methotrexate because I was really sick and this is my first winter while on the methotrexate. So then she starts asking me about vitamins - and even after I told her that I take a B complex and a multivitamin, she starts telling me about this other vitamin that you have to special order. Telling me to go take all this herbal stuff. I just said, "I'll look into it! Thanks!" with a gigantic smile on my face. I've now learned that when talking to people who think this way, it's a lot easier to nod and agree. That means I get out of the conversation faster - afterall, I'm really not gonna convince them of my view! You should have seen how many people tried to talk me out of my decision to go on the methotrexate. By the time I took the first dose, I was very worried and stressed out that I had made a bad decision and if something bad happened to me, everybody was going to say, "I told ya so! Shoulda taken this coral calcium instead of that poison!" Thank goodness it hasn't been tooooooo bad thus far - even though I'm now on the injections at a higher dose.
Re: the topamax. Rob - just about all of us in the "circles" of those who've been given topamax call it Dopeymax. PA - It's the only antiseizure drug that works on the temporal lobe. Great for temporal lobe epilepsy, but it's got some purdy cognitive side effects, no? I went up to 375mg and my story about how it nearly wrecked my life is just one of the many. The downward spiral with it started when I was performing in a scholarship competition, and about halfway through my 25pg Chopin Scherzo (Chopin Scherzo in b-flat minor for those in the know...), I had a complete memory blackout. I banged through the same page 5 times before spinning out of it and hacked the remaining half of the piece. I walked off the stage in tears at the end as my teacher sat in the audience with his jaw on the floor. I don't do that. I have a memory like a steel trap. For the remainder of my semester, I had one horrible performance, lesson, studio class after another. One day in studio class, I was playing my Beethoven sonate 2nd movement, and I was 2 measures from the end and somebody banged a locker outside the studio door...and I couldn't play the last 2 measures - my teacher had to give me the music. My best friend was allowed to sit backstage during my jury (a sort of final exam...but performance style) with my music in case I couldn't get through it. I was a piano performance major - and I thought I was developing the performance anxiety from hell. Not good when you are planning a possible career in performance... I was also taking the required classes to go to medical school - and I was getting 0's on physics quizzes. It may be easy to fail, but it's as hard to get a 0 as it is to get a 100%. My TA, who had noticed the sudden change in my quizzes, was concerned about what was going on.
After the semester ended (I'd also had to drop 8 credits to go from 21 credits as scheduled down to 13 credits - just enough to stay full time and receive my financial aid), I was admitted to the hospital by my neuro. A psychiatrist from my neuro's office came to ask how things were going, and I explained my feeling about the performance anxiety and sudden decline in school. (I should mention I was valedictorian of my high school class....that makes the grades and issues even more out of character for me!) He then said he suspected it was the topamax. At that time, this really was considered a very "rare" side effect of the drug, so nobody had really told me about it. I had been blaming all the problems on me - really had considered giving up on my education because I was afraid that I just couldn't do it anymore. My neuro later told me that I have to tell him about side effects or else he can't help me, but I said in return that I didn't know it was from the med...I thought it was me! They later started me on concerta as a trial since I was basically the first topamax patient they started on the concerta in the office to see if they could improve the cognitive function but yet keep me on the drug. (Funny, over the 2 years I was on topamax, it did not give me one single promised benefit...just a lot of grief!) The concerta did help. Every time I wanted to get off the topamax, they kept saying no - I got down to 100mg a day. Then at one point, I had enough. I took myself off it - even though I should have tapered down - I just couldn't take it anymore. I thought maybe then things would improve. I quit taking it in January 2004. Today, I'm on 36mg of Concerta in the morning and 5mg of ritalin in the afternoon. I just recently had the ritalin re-added because of having more problems again. I did terribly on my last exam and in part because every single noise in the room (as in, other students pressing the keys on the computer for the exam) was making me have to quit reading the question and start over. I've tried very hard to come off the concerta. I'm a neonatal nurse (for those who don't know) and I actually had my orientation extended by about 3 weeks when I first started because they noticed that I just couldn't stay focused and my time management sucked big time. I had toyed with coming off it - I had to go back on. It's very frustrating, for someone who never had these problems before. I feel like that drug actually changed my brain.
Sorry that's a tangent - but since others were commenting on it!
Dr. A - I do believe that patients should have an informed choice and that ultimately it is their choice. Can't say that as a patient, I've always been given good information about choices I've had to make, but I try to work harder to educate myself now...with some docs/NPs that I see, I know they do such an excellent job with presenting the whole picture for me and giving me all my options. But some of them....I walk out of there not knowing anything about the drug, and when in a very quick appointment setting like that, even when I write down my questions, sometimes it is hard for me to remember everything when having to make a decision quickly. It's impossible to know everything the doctor is going to suggest ahead of time, so I can't anticipate every single question I need to ask!
What I'm getting at is that my first comment wasn't advocating that patients shouldn't have a choice. They most certainly should. In the end, it's up to them. I just don't think that the majority of cancer patients would look at the "chemo brain" and say that it's not worth it to have the chemo...especially if not taking it might cost them their life.
And as for the statins - my dad is on tricor and lipitor, but when he collapsed and ended up in the hospital a year ago, his CPK was like off the charts high. They were concerned about the rare side effects and took him off both. He also did have elevated LFTs and some other things. But he's back on them now - and even though his CPK is still very high, it's not really changing. And the trend is more important than the number in the end - with that lab value at least. We're not sure what it's from, and we've explored almost all the options!
I still think the statins are great. I have a long way to go before I can keep them all straight (that was on my last exam....not my best performance!), but I'm also going into pediatrics... :O)
Yes, informed consent and refusal are very important things. But during all that, if I were telling somebody like our very close friend who is going through all these choices right now, l would not be doing her justice if I also didn't stress that doing the chemo really is a good choice. You can't just say (and I know you don't do this) "Well, you can do chemo (and give them info on that) or you can choose not to" and not at least guide them into what you believe is in their best interest. Otherwise, it seems like it doesn't really matter which way they choose - it's a crapshoot either way. But if it's presented as, "You can do the chemo and the info is given, and you can always choose not to, but I must say that I think the chemo is one of your best options..." - that seems like a bit more appropriate to me. If patients just have all the info but no clear guidance as to which is the clinically better option, then they just end up more worried and stressed out. I'll go back to the methotrexate issue once again...in the week after I was given the prescription, while I was still deciding whether or not to fill it, I called my internal medicine doctor. We had a long talk, and we talked about the benefits and risks, and in the end, she told me that she thought I should do it. I really respected and appreciated that, and it helped me decide to go on the med. Since it has definitely had beneficial effects for me, I'm even more glad recommended that I go along with what the other doc had prescribed. And she didn't neglect to tell me the bad effects - like how I sometimes wake up in the middle of the night and throw up all night long...and feel exhausted the day after the dose, and a few other things. But she helped me to make a clear, informed choice and also told me that she thought that was the right way to go. I could have still said no - and then I would have made a very informed refusal, but I appreciated her giving me direction.
Sorry for the length! I know it's your blog and not mine! hehe Gotta go do my ENT case study now so I can go to bed and work my 3rd 12hr shift tomorrow!
My mom had chemo and all the other treatments.. I can say from personal experience I remember that but I always wondered.. thank you for valadating my thoughts and questions.
Carrie/neonusechic/I don't know what to call you:
Now that we've totally threadjacked this about Topamax... I'm sorry you had to go through such a rough experience with it. Yes, since it hits the temporal lobe so hard, it can either be a "hit or miss" drug. People either love it or hate it, can hack it or simply can't tolerate it.
And...it's also not usually considered to work well in monotherapy for that reason. Which makes me a freak because it's the only anticonvulsant I'm on for bipolar. For seizures, I have an adjunct (and it's technically a benzo.) But for bipolar, the Topa. seems to work just fine on it's own. How strange is that?
But we'll see what my new psychiatrist has to say about that haha.
There is definitely such thing as chemo brain - last week my mom had to ask me what her birthday is, and she is a very intelligent woman - normally not scatterbrained in the least.
Although perhaps not 'officially proven' previously, I think those in the oncology field have been aware of chemo brain as a side effect for a while. I heard of it maybe 1 1/2 years ago (via an oncology nurse).
You know, I've often wondered if I'd choose any therapy if given a cancer diagnosis.
I'm not afraid of death, so I'm not sure which scares me more - a diagnosis of cancer or the side effects of trying to kill the cancer.
I hope I never have to deal with having to make that decision.
On a different note, I firmly believe that is statins had been around fifteen years ago, my father would be alive today. Long live Lipitor! It's the one drug I have no interest in stopping!
I have chemo brain from chemotherapy that I started two years ago. I was not told about chemo brain or most of the other side effects of the drugs, and I don't think it would have mattered. My focus then was what do I have to do to get well. After living with the mess that that the therapy for cancer has done to my body I'd like to think that I'd ask what any new therapies are going to do and make a decision on whether the treatment is worse than the disease. Now that I have a recurrance of the cancer, I know that I'm probably not going to do that. My biggest question again is "what do I need to do to beat this thing again?" The survival instinct kicks in and it is amazing what people do.
The hardest part of chemo brain is that nobody recognizes it. I went back to work and had conflict because I wasn't able to perform at the level I was at before. Being a communicator, I forget words and have to wait for them to come back. I used to be a graceful dancer, now I trip on the carpet. I know what chemo brain is, but most people have never heard of it.
I will never understand why any intelligent human being would allow doctors to strap them down and insert toxic chemicals like mustard gas, and ddt derivatives into their body, all the while BELIEVING it will 'cure' them. In even best cases, only 28% of patients can expect the disease never to return. In the rest the primary disease is terminated, but the treatment causes it to come back in different body areas and much more aggressive. Bottom line, we cannot determine our day or method of passing, but we can go with DIGNITY, not go out vomiting up our intestinal lining, bald, and poisoned from the inside out.
This brain fog issue is real. I have it and I have met many other people who have it as well, not from chemotherapy, but from toxic mold exposure. We had the mold in our building tested not just for what species it was, but also for mycotoxins, and it was toxic for trichothecene mycotoxins which are cytotoxic and also immunosuppressive. Both trichothecenes and ochratoxin A are extremely toxic to these so called progenitor cells or neural stem cells that the brain uses to repair itself. The effect is that it destroys your short term memory and it also damages your executive function. That is just one of the long list of heath issues I have now. I was healthy when I moved in to that place. Want to know the crime? Doing this to people appears to be completely legal. They can get away with doing it again and again and never clean it up.
I'm just curious. Do many of those people who get cancer and then get chemo brain then lose their demanding jobs then lose their health insurance?
It seems awfully stupid to tie healthcare to one's job because (duh) when you get really sick you often can't work.
Then you lose your health insurance. Then they take everything you own.
I read recently that health insurance companies take ONE THIRD of all money spent on healthcare in the US.
There has to be a better way. We can't wait another decade or so while they argue this point. People are dying. Healthcare should be a universal benefit of living in this so called rich nation.
Provenge and Our F.D.A.’s Overt Absent of Loyalty
Terminal patients are those who are not expected to live due to usually illness such as advanced prostate cancer (cT3). If the patient has 6 months or less to live, those patients are considered terminally ill. Regardless, if a patient is terminal, they are without a cure or tolerable treatment for their illness. Since such patients will likely die in a short period of time, treatment options, even if unproven, are often desired by such patients. This is understandable, because at such a severe stage of illness, such as prostate cancer, possible extension of their lives with comfort is worth it to them, regardless of lack of evidence of proof of whatever treatment that may be advantageous to them regarding these issues. The FDA, however, claims authority on the treatment options of such patients, although that administration has proven itself over the years to be rather inadequate with its frequent drug recalls and black box warnings, and they do these things only under pressure from the public, usually.
Prostate cancer is a rather frequent occurrence- with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in about 30,000 deaths a year from this disease of the one million men who have prostate cancer in the United States. Furthermore, there are different stages of prostate cancer, and the more severe the prostate cancer cases are which is determined by such methods as bone scans and Gleason’s scores, which is a score that assesses prostate tissue after it is biopsied and if it is determined that the stage of cancer is severe by this and to estimate proper treatment options if proven to be malignant. Typically, the initial suspicion of prostate cancer is determined by the results of what is called a PSA blood test, as PSA is a protein produced by prostate cancer cells. If the PSA blood test is above normal limits, a prostate biopsy is performed to determine and confirm not only the presence of cancer, but also the severity of the disease on such a patient.
Yet fortunately, and as you will read, innovation still exists in medicine. A few years ago, a small Biotechnology company called Dendreon was working on a conceptually new treatment for the worst prostate cancer patients, and this treatment therapy created by Dendreon was named Provenge. Provenge is the first immunotherapy biologic treatment for the progressed prostate cancer patients, and has proven to be a very novel and innovative treatment option for advanced prostate cancer patients who are terminally ill. Usually, these patients are unresponsive to usual treatment methods for prostate cancer, and are left with chemotherapy as their only treatment option at such a traumatic stage of prostate cancer. Understandably, most patients at this stage refuse treatment entirely, largely due to the brutal side effects of such chemotherapy treatments as taxotere. The immunotherapy method developed by Dendreon required the removal of white blood cells of the diseased patient and, after altered, are re-injected into this patient now designed to attack what is called PAP, which is on prostate cancer cells only. This treatment required only three such injections in a period of six weeks. This resulted in life extension twice that of chemotherapy treated prostate cancer patients of this severity, and without the concerning side effects of chemotherapy. The medical community and survivors of prostate cancer were elated and waited with great anticipation for access to this treatment method.
Fortunately, as the years passed, Provenge, by 2007, had convinced others of its safety and efficacy in its benefit for severe prostate cancer patients. This caused great joy to such patients and their families. Perhaps greater elation was experienced by the caregivers and specialists of such a disease, such as Urologists and Oncologists who treat such patients. While Provenge was on fast track status at this time at the FDA, the FDA panel thankfully recommended with clarity the approval of Provenge based on its proven and substantial efficacy and safety demonstrated in its performance in past trials. The FDA announced this to the public in the early Spring of 2007, I believe.
Now for the bad news: With great shock and surprise, the FDA agency rejected the approval of this great treatment for very sick patients due to, they said, ‘lack of data’ in May of 2007. This contradicts their favorable opinion of Provenge weeks before delivering this terrible news. Especially when one considers the FDA Commissioner is a prostate cancer survival himself!
Soon after this judgment was passed by the FDA, conflicts of interest were discovered by others. For example, a member of the FDA agency who was evaluating Provenge, Dr. Scher, was found to have a financial commitment to a future competitor of Provenge that was being produced by a company called Novacea, and this company had signed a co-promotion agreement with Schering with this similar prostate cancer drug being developed by this company. Dr. Scher never disclosed this conflict during the approval process of Provenge. As it turns out, this anticipated prostate cancer drug made by Novacea was discovered to have serious flaws, and Schering pulled out of the agreement with Novacea. In addition to this incident and before May of 2007, baseless letters were anonymously delivered to the FDA stating negative qualities about Provenge that were without Merit and speculative claims about the treatment. Yet overall, the disapproval by the FDA of Provenge angered many, and a newly formed advocacy group called Care to Live filed a lawsuit against the FDA for their clear lack of protocol or knowledge about such complex treatment agents as Provenge at the end of last year.
Terminal patients, I surmise, desire comfort during their progressive disease that has placed them in the last chapter of their lives, and certainly should have a right to choose any treatment that possibly could benefit them. At this stage of such a patient, one could argue, safety of any treatment option is not of concern to these patients, because they are going to die anyway. Yet the FDA, with reckless disregard and overt harshness for these very ill patients, ultimately harmed others more by not approving Provenge with deliberate intent.
The FDA does in fact presently have the ability to grant what is called conditional approval for such treatment methods as Provenge, and why they have not expanded this approval process to all terminally ill patients remains completely unknown. What is known is that they are harming those they pledged to protect so long ago by depriving such patients in need of treatment, as no other options are viable presently that are as safe and effective with great tolerability associated with Provenge. So now the FDA appears to be a bought, corrupt, and incompetent administration without loyalty and dedication to the public and its health. This needs to be corrected in any way possible for the lives of others. A terminally ill patient has a personal right to obtain and access such treatments upon their own volition as well as the discretion of their doctor, just as a terminally ill patient is granted an individual right to die, if they choose to do so. It is an individual decision in such cases that should be void of interference from others.
“Facts do not cease to exist because they are ignored.” --- Aldous Huxley
The effect is that it destroys your short term memory and it also damages your executive function.
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